Condition category
Surgery
Date applied
24/06/2010
Date assigned
24/06/2010
Last edited
29/05/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr Sukumaran Nair

ORCID ID

Contact details

Papworth Hospital NHS Foundation Trust
Papworth Everard
Cambridge
CB23 3RE
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

7766

Study information

Scientific title

A pragmatic, prospective, randomised controlled trial comparing upper ministernotomy to full median sternotomy as a surgical approach for aortic valve replacement

Acronym

MiniStern Trial

Study hypothesis

MiniStern is a pragmatic, prospective randomised controlled trial comparing upper mini-sternotomy to full median sternotomy as a surgical approach to first time isolated aortic valve replacement (AVR).

Ethics approval

MREC approved (ref: 09/H0301/58)

Study design

Single-centre randomised interventional treatment trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Topic: Cardiovascular, Generic Health Relevance and Cross Cutting Themes; Subtopic: Cardiovascular (all Subtopics), Generic Health Relevance (all Subtopics); Disease: Cardiovascular, Surgery

Intervention

Comparing upper mini-sternotomy to full median sternotomy as a surgical approach to first time isolated aortic valve replacement (AVR).

Intervention type

Procedure/Surgery

Phase

Not Applicable

Drug names

Primary outcome measures

Total length of stay in hospital for the index AVR operation measured in days

Secondary outcome measures

1. Fitness for discharge
2. Health related quality of life and patient satisfaction at baseline, 6 weeks, 6 months and 12 months using the 36-item short form health survey (SF-36) and Coronary Revascularization Outcome Questionnaire - Coronary Artery Bypass Graft (CROQ-CABG)
3. Heart function (LVEF) by echocardiography at baseline, day of discharge and 6 months post surgery
4. Procedure time: total theatre time, cross clamp time, cardiopulmonary bypass time, blood loss, blood transfusion
5. Respiratory function (forced expiratory volume in one second [FEV1]) by hand held spirometry at baseline, day 4, day of discharge, 6 weeks and 6 months

Overall trial start date

30/11/2009

Overall trial end date

01/09/2012

Reason abandoned

Eligibility

Participant inclusion criteria

1. Aged greater than 18 years at the time of surgery, either sex
2. Elective, first time, isolated aortic valve replacement (AVR)

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

Planned sample size: 240

Participant exclusion criteria

1. Documented poor left ventricular (LV) function or left ventricular ejection fraction (LVEF) 30%
2. Documented chest wall deformities
3. Documented severe emphysema or chronic obstructive pulmonary disease (COPD)
4. Current body mass index (BMI) greater than 35 kg/m^2
5. Concomitant cardiac surgery
6. Redo surgery
7. Median sternotomy indicated

Recruitment start date

30/11/2009

Recruitment end date

01/09/2012

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Papworth Hospital NHS Foundation Trust
Cambridge
CB23 3RE
United Kingdom

Sponsor information

Organisation

Papworth Hospital NHS Foundation Trust (UK)

Sponsor details

Papworth Everard
Cambridge
CB3 8RE
United Kingdom

Sponsor type

Government

Website

http://www.papworthhospital.nhs.uk/index.php

Funders

Funder type

Government

Funder name

National Institute for Health Research (NIHR) (UK) - Central Commissioning Facility (CCF)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes